NDAORALTABLET
Approved
Jul 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
ZEBETA (bisoprolol fumarate) by Teva is clinical pharmacology bisoprolol fumarate tablets are a beta 1 -selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range. First approved in 1992.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEBETA (bisoprolol fumarate) is a beta-1 selective (cardioselective) adrenergic receptor blocker approved in 1992 for the treatment of hypertension and angina. It works by reducing heart rate and cardiac output through selective inhibition of beta-1 receptors, with minimal effects on beta-2 receptors at therapeutic doses. The drug is administered orally once daily with high bioavailability (~80%) and reaches steady state within 5 days.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling a transition from brand maintenance to generic defense strategies and potential team consolidation.
Mechanism of Action
CLINICAL PHARMACOLOGY Bisoprolol fumarate tablets are a beta 1 -selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range. Cardioselectivity is not absolute, however, and at higher…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.